Designated experts will be in charge of generating standard operating procedures (SOPs), individual case study reports, literature screening, and regulatory expedited reporting and storing real-world evidence (RWE) of adverse events conveyed by doctors and patients post-market.
The pharmacovigilance systems division is constantly improving, and always keeping in line with, changing regulations and requirements for the health authorities/ business, making this a very challenging and vital aspect of pharma drug safety.
RegPakBioPharma Consulting is a specialist in the entire realm of pharmacovigilance (PV).
When it comes to strategic planning for product development, it can assist with the preparation and medical writing of key proofs of satisfactory pharmacovigilance that are required for marketing authorization by the Global Regulatory Authorities.
One of the most vital functions within a life science company is Pharmacovigilance. To develop, manufacture, and commercialize a drug a company must adhere to strict regulations.
Most of the protocols will focus on safety and the added benefit to the final consumer. This is the mission of drug safety and this is the reason why this discipline plays such a pivotal role within pharmaceuticals.
